Penumbra, Inc. Announces Results of its Sponsored PROMISE Study
January 25, 2018 at 08:00 am
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Penumbra, Inc. announced results of the company-sponsored PROMISE Study, demonstrating real-world safety and efficacy of the Penumbra System with ACE™68 and ACE™64 Reperfusion Catheters as frontline treatment in patients with acute ischemic stroke using the ADAPT (ADirect Aspiration First Pass Technique) approach. The results were presented last night at the International Stroke Conference (ISC 2018) in Los Angeles. The PROMISE Study was a prospective, single-arm multi-center study that enrolled 204 patients across 20 European centers. Core-lab adjudicated mTICI 2b-3 revascularization was attained in 93.1% of patients, with 39.2% of patients attaining mTICI 3 revascularization. Clinical independence, measured by modified Rankin Score (mRS) 0-2, was achieved in 61% of patients at 90 days. Key secondary safety related endpoints also demonstrated excellent results: All-cause mortality at 90 days was 7.5%, symptomatic intracranial hemorrhage (sICH) at 24 hours was 2.9% and embolization in new territories (ENT) was 1.5%. Median procedure time, as measured as groin puncture to mTICI 2b-3 revascularization, was 31 min [20.0 – 53.0]. Results of an additional study evaluating Penumbra’s aspiration thrombectomy system for ischemic stroke revascularization using the ADAPT approach, the COMPASS Trial (A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach), will be presented later in the main event plenary session at the International Stroke Conference from 11-11:12 a.m. PT.
Penumbra, Inc. is a healthcare company. The Company designs, develops, manufactures, and markets products and has a portfolio that addresses challenging medical conditions in markets with unmet need. It is focused on developing, manufacturing, and marketing products for use by specialist physicians and healthcare providers to drive improved clinical and health outcomes. It is focused on developing and building its portfolio of products, including its thrombectomy, embolization, access, and immersive healthcare technologies. Common conditions that the Company focuses on Pulmonary Embolism, Deep Vein Thrombosis, Peripheral Arterial Occlusion, Ischemic Stroke, Acute Coronary Syndrome, Clot associated with Arteriovenous Graft or Fistula, Aneurysm, and Hemorrhagic Stroke. The Company sells its products to healthcare providers primarily through its direct sales organization in the United States, Europe, Canada and Australia, as well as through distributors in select international markets.